Obstetric Pain Management for Women With Opioid Use Disorder (QUEST)

NCT04308655 | Completed

• 1 other identifier: STUDY20010041
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This is a mixed methods longitudinal observational study to assess patient and provider perspectives on pain and pain management among pregnant women with opiate use disorder (OUD). The findings from this study will inform patient-centered approaches to pain management. Themes surrounding mothers' pain/recovery experiences that correlate with quantified pain and analgesia endpoints will be identified. Findings will also shape an appropriate patient-centered research agenda for obstetric pain management in patients with OUD.

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (1)

• Themes surrounding mothers' pain/recover experience

  The endpoint of this mixed-methods investigation is to identify themes surrounding mothers' pain/recovery experiences that correlate with quantified pain and analgesic needs. Endpoint will take the form of words/terms, phrases, or sentences. Identification of these terms, phases, or sentences are not identified a priori in this qualitative investigation.

  Through study completion, an average of 6 weeks (from enrollment through labor and delivery)

Study Arms (2)

Patient participants

This cohort will include pregnant patients with a history of opiate use disorder (OUD) who will be followed from the third trimester of pregnancy until five days postpartum.

Other: Interview; Other: Surveys

Provider participants

This cohort will include clinicians who provide care for pregnant patients with OUD. Providers will be interviewed and will complete one survey cross-sectionally.

Other: Interview

Interventions

Interview OTHER

Semi-structured interviews

Patient participants; Provider participants

Surveys OTHER

Validated surveys on pain, fear, anxiety, depression, beliefs

Patient participants

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll pregnant adults with opiate use disorder (on medication assisted therapy) who are currently in their third trimester.

You may qualify if:

• Pregnant women who are 18 years of age or older
• History of opioid use disorder, on medication assisted therapy
• Currently in their third trimester

You may not qualify if:

• Unable to participate in informed consent discussions
• Unable to give informed consent for any reason
• Not fluent in English (surveys are validated in English language)
• Unable to participate fully in all study procedures for any reason

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Magee Womens Hospital

Pittsburgh, Pennsylvania, 15215, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Interviews as Topic; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Grace Lim, MD MS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 16, 2020
• Study Start: March 6, 2020
• Primary Completion: May 1, 2021
• Study Completion: March 31, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)